FDA Drugs@FDA Application Lookup

One record per FDA drug application (NDA, ANDA or BLA) that matches your search: sponsor company, application number, brand or active ingredient, narrowed by application type, marketing status and the kind and date of FDA action. Each record carries the application's products and its full submissions timeline: original approval date, tentative approval, and the latest action with its approval letter and label links. Built for pharma BD, competitive-intelligence and regulatory teams who need "every approval Teva got for this ingredient" or "which original NDAs were approved this month", not a bulk data dump.

Pricing: pay per event. application-record — one event per application returned. A search with no matches costs you nothing.

A search is required: at least one of sponsors, application numbers or drug keywords. The one exception is a recent-actions feed: a window of 1–90 days plus at least one kind filter (application type, submission type, status, class, review priority or orphan). Different fields combine with AND; entries within one field combine with OR.

Submission filters apply to one action. "Original approvals in the last 30 days" means a single ORIG submission approved inside the window, not an old original plus a recent labeling supplement. openFDA's own search matches those conditions across different submissions: in a live check, 61 of 74 hits for that query were near-misses. This Actor re-checks every hit and never charges for one.

Input

{"sponsors": ["teva pharms"], "drug_keywords": ["atorvastatin"],
 "marketing_statuses": ["prescription"]}

Recent original approvals of new drugs and biologics:

{"application_types": ["NDA", "BLA"], "submission_types": ["ORIG"],
 "submission_statuses": ["AP"], "since_days": 30}

Sponsor names are matched anywhere in the sponsor as FDA records it. FDA often abbreviates them (TEVA PHARMS USA, DR REDDYS LABS LTD), so the shortest distinctive word works best. Scheduled watches: set an action window and turn on Only actions not reported before. An application is then returned and charged again only when it gets a new matching action.

Example output (one dataset item per application; lists abridged)

{"application_number": "NDA213871", "application_type": "NDA",
 "sponsor_name": "PFIZER", "brand_names": ["CIBINQO"],
 "active_ingredients": ["ABROCITINIB"], "dosage_forms": ["TABLET"],
 "routes": ["ORAL"], "marketing_statuses": ["Prescription"],
 "products": [{"product_number": "003", "brand_name": "CIBINQO",
   "active_ingredients": [{"name": "ABROCITINIB", "strength": "200MG"}],
   "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription",
   "te_code": null, "reference_drug": true, "reference_standard": true}],
 "original_approval_date": "2022-01-14", "tentative_approval_date": null,
 "latest_action": {"type": "SUPPL", "number": "3", "status": "AP",
   "status_date": "2026-09-02", "review_priority": "STANDARD",
   "class_code": "LABELING", "class_description": "Labeling", "orphan": false,
   "docs": [{"type": "Letter", "date": "2026-09-04",
     "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213871Orig1s003ltr.pdf"},
     {"type": "Label", "date": "2026-09-08",
     "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213871s003lbl.pdf"}]},
 "latest_action_date": "2026-09-02", "submission_count": 5,
 "matched_submissions": [{"type": "SUPPL", "number": "3", "status": "AP",
   "status_date": "2026-09-02", "class_code": "LABELING", "docs": ["…"]}],
 "submissions": [{"type": "SUPPL", "number": "3", "status": "AP",
   "status_date": "2026-09-02", "class_code": "LABELING"}, "…"],
 "generic_names": ["ABROCITINIB"],
 "manufacturer_names": ["U.S. Pharmaceuticals", "Pfizer Laboratories Div Pfizer Inc"],
 "pharm_class_epc": ["Janus Kinase Inhibitor [EPC]"],
 "drugsfda_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213871",
 "data_last_updated": "2026-09-22"}

Output fields

One dataset item per result. Every field is always present (empty or null when the source has no value). Defined in .actor/dataset_schema.json.

Field	Type	Description
application_number	string	NDA, ANDA or BLA plus 6 digits
application_type	string or null	NDA, ANDA or BLA
sponsor_name	string or null	Sponsor (applicant) as FDA records it
brand_names	array	Distinct product brand names
active_ingredients	array	Distinct active-ingredient names
dosage_forms	array	Distinct dosage forms
routes	array	Distinct routes of administration
marketing_statuses	array	Distinct product marketing statuses
products	array	Per product: number, brand, ingredients with strength, dosage form, route, marketing status, therapeutic-equivalence code, reference drug / reference standard flags
original_approval_date	string or null	Approval date of the original application, YYYY-MM-DD
tentative_approval_date	string or null	Tentative approval date of the original application, if any
latest_action	object or null	Most recent submission action, with its documents (letters, labels)
latest_action_date	string or null	Date of the most recent action
submission_count	integer	Submissions on file (original + supplements)
matched_submissions	array	Actions that met every submission filter on the same submission, newest first, with documents. With "only new actions" on, only the ones not reported before. Empty when no submission filter is set.
submissions	array	Submission timeline, newest first (max 200), without documents
generic_names	array	openFDA generic names (empty when openFDA has no label link)
manufacturer_names	array	openFDA labeler / manufacturer names
pharm_class_epc	array	Established pharmacologic class
drugsfda_url	string	The application's Drugs@FDA page
data_last_updated	string or null	When openFDA last refreshed Drugs@FDA, YYYY-MM-DD

Runs stop cleanly at your max-charge limit: nothing is pushed past what you agreed to pay for.

Coverage and freshness

• What's in: Drugs@FDA holds FDA-approved and tentatively approved NDAs (brand drugs), ANDAs (generics), and the therapeutic biologics regulated by CDER: 29,347 applications on 2026-09-23 (5,890 NDA, 22,974 ANDA, 483 BLA).
• What's out: biologics regulated by CBER, such as vaccines, blood products, and cell and gene therapies (COMIRNATY, SHINGRIX and KYMRIAH aren't in it). Neither are pending or refused applications, or OTC monograph drugs without an application.
• Freshness: openFDA refreshes Drugs@FDA a few times a week and runs a couple of business days behind FDA's own site. On 2026-09-23 the data carried actions through 2026-09-18, while FDA's site showed 2026-09-22. Every record shows data_last_updated.

Source: the openFDA drug/drugsfda API (public, CC0). Without a key, openFDA allows 1,000 requests per day per IP address, and Apify IPs are shared, so heavy schedules should add a free openFDA API key. openFDA's disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated." This Actor isn't affiliated with or endorsed by the FDA. Also see the FDA Recall Monitor for drug, food and device recalls, and the FDA 510(k) / PMA Clearance Monitor for medical-device decisions.